Project

General

Profile

Actions

Feature #1253

open
RA

[B] PrediSurge — Bruno Virieux (pharma_medtech_exec) [GYJ]

Feature #1253: [B] PrediSurge — Bruno Virieux (pharma_medtech_exec) [GYJ]

Added by Redmine Admin about 1 month ago. Updated about 1 month ago.

Status:
Design
Priority:
Normal
Assignee:
-
Start date:
06/25/2026
Due date:
% Done:

0%

Estimated time:
spec_ref:
build_status:
build_number:
ci_run_url:
scan_status:
scan_report_url:
deploy_status:
preprod_url:
deployed_at:
branch:
pr_url:
security_key:
severity:
paused:

Description

**Source:** GetYourJob (classified health-software, actively hiring developers)
**Founder:** Bruno Virieux — CEO (since December 2022). Founders: Jean-Noel Albertini (co-founder & CMO, vascular surgeon), David Perrin (co-founder & CTO), Stephane Avril, Alban Molle
**Background:** pharma_medtech_exec | verified: False — PrediSurge's founders are academic/clinical researchers, NOT pharma/medtech executives. The company is a 2017 spin-off of Mines Saint-Etienne (IMT). Founders: (1) Jean-Noel Albertini, co-founder & CMO/Chief Medical Officer, is a vascular surgeon and international key opinion leader on aortic endovascular repair, whose academic research initiated the company; (2) David Perrin, co-founder & CTO, is an engineer who defended his PhD in 2015 on patient-specific simulation of aortic endovascular repair; (3) Stephane Avril, co-founder, is a Full Professor of soft-tissue biomechanics at Mines Saint-Etienne / IMT (academic, not an executive); (4) Alban Molle, co-founder (limited public background). Separately, the CEO since December 2022, Bruno Virieux, is the only figure who fits a 'medtech exec' description: a graduate of Ecole Centrale de Lyon with 20+ years in the medical-technology sector. He is NOT a founder, and his background is medtech/machine-learning, not pharma. So the 'pharma_medtech_exec' label is wrong for the founders (surgeon + engineers + professor), and even for the CEO 'pharma' is inaccurate (medtech, not pharma).
**Stage / fundraise:** Series A, ~28 employees, founded 2017, commercializing CE-marked products (iSizing launched 2025) / Closed a EUR 6.5M Series A in 2023 (EUR 4M equity), led by Liftt with EIC Fund, Saint Victor Capital, UI Investissement - Metropoles Innovations, and Credit Agricole LHL Capital Innovation; preceded by a EUR 1.5M round in 2020 and a EUR 2.5M EIC Accelerator grant (announced April 2023).
**Regulatory trigger:** Class IIa Software as a Medical Device under EU MDR. PlanOp Aortic V2 and PlanOp/iSizing V1 are Class IIa, CE-marked (notified body 0123). Company holds an EU MDR Quality Management System certificate (2023) and ISO 27001. Class IIa SaMD requires notified-body conformity assessment, IEC 62304 lifecycle, and full technical documentation - exactly the regime OmDev's compliance pipeline (SOUP register + requirements-to-code-to-test traceability) supports.
**Email:** (confidence medium) — Not a published personal address. The published generic address is . RocketReach reports the company email pattern as (used by 100% of sampled addresses), so is a pattern-based inference, not a confirmed published email.
**LinkedIn:** https://www.linkedin.com/company/predisurge/ (company page; CEO personal profile not verified) **Website:** https://www.predisurge.com
**Score:** 8 -> Tier B
**Hook:** PrediSurge is a well-funded (EUR 6.5M Series A) Class IIa SaMD scale-up that is hiring developers while industrializing PlanOp and pushing into new cardiac/structural segments. OmDev's senior team + dedicated CTO + built-in compliance engine (SOUP register signed each build, full requirements-to-code-to-test traceability for the IEC 62304/MDR file) lets them add regulated-software capacity at a fixed monthly price ~3x cheaper than expanding the in-house team - turning each developer hire into a managed pod that feeds their existing QA/RA function instead of a slow, costly headcount ramp.

---

## Founder & background
CEO Bruno Virieux (since Dec 2022) is a Machine Learning specialist with 20+ years in medical technology - a pharma/medtech exec profile, not finance/insurance ([about-us](https://www.predisurge.com/about-us/)). The company is a Mines Saint-Etienne spin-off founded in 2017 by a clinical/academic team: vascular surgeon & KOL Jean-Noel Albertini (CMO), engineer-PhD David Perrin (CTO), Stephane Avril and Alban Molle ([Mines Saint-Etienne](https://www.mines-stetienne.fr/en/actualites/predisurge-at-the-forefront-of-medical-technologies-for-endovascular-surgery)).
No finance/insurance founder found - this is an academic-deeptech rather than a non-technical-founder profile, which slightly weakens the ICP fit.

## Funding & momentum
Closed a EUR 6.5M Series A in 2023 (EUR 4M equity), led by Liftt with the EIC Fund, Saint Victor Capital, UI Investissement and Credit Agricole LHL Capital Innovation ([Journal des Entreprises](https://www.lejournaldesentreprises.com/auvergne-rhone-alpes/breve/predisurge-leve-65-millions-deuros-pour-developper-son-jumeau-numerique-cardiovasculaire-2072285); [UI Investissement](https://fr.linkedin.com/posts/ui-investissement_predisurge-achieves-65-million-in-series-activity-7122571315286269952-RxVd)).
Earlier: EUR 1.5M (2020) plus a EUR 2.5M EIC Accelerator grant ([Usine Nouvelle](https://www.usinenouvelle.com/article/communique-loire-un-financement-de-2-5-millions-d-euros-de-la-commission-europeenne-pour-l-entreprise-predisurge.N2212852)). ~28 employees - a funded scale-up, not a pre-seed garage.

## Product & regulatory
Patient-specific digital-twin / predictive simulation for vascular, endovascular and structural-heart surgery ([tech.eu](https://tech.eu/2024/02/06/meet-the-french-company-pioneering-digital-twins-for-cardiovascular-procedures/)). Product line: PlanOp Virtual Lab, iSizing (automated CE-marked EVAR sizing, 2025), MPR View & Share, Endoleak Risk Index.
Regulatory: Class IIa SaMD under EU MDR; PlanOp Aortic V2 / iSizing are CE-marked (NB 0123), with an EU MDR QMS certificate (2023) and ISO 27001 ([PlanOp x Medtech](https://www.predisurge.com/planop-x-medtech/); [about-us](https://www.predisurge.com/about-us/)). Class IIa demands IEC 62304 lifecycle + notified-body assessment.

## Pain & buying signals
They are actively hiring developers (GetYourJob health/software + dev-hiring signal; Tech roles on [Welcome to the Jungle](https://www.welcometothejungle.com/en/companies/predisurge/jobs)). Caveat: they already run a real in-house team - CTO David Perrin, Head of R&D Florian Cotte (PhD), Head of Production, and a dedicated QA & Regulatory Affairs Manager since 2019 ([about-us](https://www.predisurge.com/about-us/)). So the gap is dev-throughput on a regulated multi-product roadmap (industrializing PlanOp, expanding into cardiac/structural), not an absent team. No evidence of agency dependence or an imminent audit deadline.

**Why OmDev fits:** A funded Class IIa SaMD company scaling its regulated codebase is OmDev's sweet spot for capacity. A managed senior pod + dedicated CTO at a fixed price ~3x cheaper than in-house headcount lets PrediSurge accelerate the PlanOp/cardiac roadmap, and OmDev's compliance engine (SOUP register signed each build + requirements-to-code-to-test traceability) plugs directly into their existing QA/RA function and MDR/IEC 62304 file. Tier B (not A): mature in-house dev + QARA and a tech/medtech-exec (not finance/insurance) founder lower ICP fit, while strong funding and a clear regulated-build need keep it a worthwhile target.

---
**Sources:** https://www.predisurge.com/about-us/ · https://tech.eu/2024/02/06/meet-the-french-company-pioneering-digital-twins-for-cardiovascular-procedures/ · https://www.lejournaldesentreprises.com/auvergne-rhone-alpes/breve/predisurge-leve-65-millions-deuros-pour-developper-son-jumeau-numerique-cardiovasculaire-2072285 · https://fr.linkedin.com/posts/ui-investissement_predisurge-achieves-65-million-in-series-activity-7122571315286269952-RxVd · https://www.usinenouvelle.com/article/communique-loire-un-financement-de-2-5-millions-d-euros-de-la-commission-europeenne-pour-l-entreprise-predisurge.N2212852 · https://www.predisurge.com/planop-x-medtech/ · https://www.welcometothejungle.com/en/companies/predisurge/jobs · https://www.mines-stetienne.fr/en/actualites/predisurge-at-the-forefront-of-medical-technologies-for-endovascular-surgery · https://rocketreach.co/predisurge-email-format_b40a11f3ffae2489 · https://www.linkedin.com/company/predisurge/

RA Updated by Redmine Admin about 1 month ago Actions #1

  • Status changed from Submitted to Design

DRAFT Email 1 (outcome-sell, 3x):

To: Bruno Virieux — (confiance medium) · Redmine #1253
From:
Objet: capacité dev régulée pour planop

Bonjour Bruno,

J'ai vu que PrediSurge recrute des développeurs en ce moment, en pleine industrialisation de PlanOp et sur de nouveaux segments cardiaques.

Chez OmDev, on propose une autre voie pour ajouter de la capacité dev régulée: une équipe senior et un CTO dédié à budget mensuel fixe, environ 3 fois moins cher que de recruter l'équivalent en interne, sans rien lâcher sur les normes (IEC 62304, MDR).

Notre chaîne produit la preuve au fil de l'eau: registre SOUP signé à chaque build, traçabilité entre les exigences, le code et les tests, de quoi alimenter directement votre fonction QA/RA. Le code reste chez vous.

On en parle 15 minutes? https://calendly.com/pollet-dam/discussion ou répondez-moi simplement.

Si ce n'est pas le moment, dites-le et je n'insiste pas.

Damien
OmDev, omdev.tech

Actions

Also available in: PDF Atom